US10117765B2 - Apposition fiber for use in endoluminal deployment of expandable implants - Google Patents

Abstract

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise an apposition line or lines which facilitate bending of the expandable implant to improve conformation of the expandable implant to the vasculature of the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser. No. 61/496,966, entitled “APPOSITION FIBER FOR USE IN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE IMPLANTS IN TORTUOUS ANATOMIES” filed Jun. 14, 2011, which is hereby incorporated by reference in its entirety.

BACKGROUND

Field

The present disclosure relates generally to expandable implants and, more specifically, to orienting and positioning endoluminally-delivered expandable implants within the vasculature of a patient.

Discussion of the Related Art

Endoluminal therapies typically involve the insertion of a delivery catheter to transport a prosthetic implant into the vasculature through a small, often percutaneous, access site in a remote vessel. Once access to the vasculature is achieved, the delivery catheter is used to mediate endoluminal delivery and subsequent deployment of the implant via one of several techniques. In this fashion, the implant can be remotely delivered to achieve a therapeutic outcome. In contrast to conventional surgical therapies, endoluminal treatments are distinguished by their “minimally invasive” nature.

Endoluminally-deliverable expandable implants can be comprised of a graft or a stent component with or without a graft covering over the stent interstices. They can be designed to expand when a restraint is removed or to be balloon-expanded from their delivery diameter, through a range of intermediary diameters, up to a maximal, pre-determined functional diameter. The endoluminal delivery and deployment of expandable implants pose several unique problems. For example, the expandable implant itself must be constrained in a suitable introductory size (or delivery diameter) to allow insertion into the vasculature and mounted onto a delivery device such as a catheter shaft. In such configurations, the expandable implant can be difficult to navigate through vasculature that has significant bending or curvature.

Therefore, it is desirable to provide systems for endoluminal delivery of expandable implants to vascular treatment sites, particularly along tortuous vasculature, such as along the aortic arch.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure, wherein:

FIG. 1 illustrates a side view of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIG. 2 illustrates a perspective view of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIGS. 3A-3E illustrate a perspective view, two cross-sectional views, and two other perspective views, respectively, of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIGS. 4A and 4B illustrate partial cross-sectional views of a catheter assembly having an expandable implant;

FIG. 5 illustrates a perspective views of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIGS. 6A-6D illustrate side views of various stages of deployment of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIG. 7 illustrates a front view of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIG. 8 illustrates a front view of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIG. 9 illustrates a front view of a catheter assembly having an expandable implant in accordance with the present disclosure;

FIG. 10 illustrates a perspective view of a catheter assembly having an expandable implant in accordance with the present disclosure; and

FIG. 11 illustrates various profile views of a distal end of an expandable implant.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. Stated differently, other methods and apparatuses can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale, but can be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. Finally, although the present disclosure can be described in connection with various principles and beliefs, the present disclosure should not be bound by theory.

Throughout this specification and in the claims, the term “distal” refers to a location that is, or a portion of an expandable implant (such as a stent-graft) that when implanted is, further downstream with respect to blood flow than another portion of the implant. Similarly, the term “distally” refers to the direction of blood flow or further downstream in the direction of blood flow.

The term “proximal” refers to a location that is, or a portion of an expandable implant that when implanted is, further upstream with respect to blood flow than another portion of the implant. Similarly, the term “proximally” refers to the direction opposite to the direction of blood flow or upstream from the direction of blood flow.

With further regard to the terms proximal and distal, and because the present disclosure is not limited to peripheral and/or central approaches, this disclosure should not be narrowly construed with respect to these terms. Rather, the implants and methods described herein can be altered and/or adjusted relative to the anatomy of a patient.

Throughout this specification and in the claims, the term “leading” refers to a relative location on a catheter assembly which is closer to the end of an implant that is inserted into and progressed through the vasculature of a patient. The term “trailing” refers to a relative location on a catheter assembly which is closer to the end of an implant that is located outside of the vasculature of a patient.

In various embodiments, a catheter assembly is disclosed which utilizes one or more flexible sleeves that (i) releasably constrain an expandable implant, such as an expandable stent graft, in a dimension suitable for endoluminal delivery of the implant to a treatment site, such as a vascular member in a patient's body; and (ii) further constrain the implant to an outer peripheral dimension that is larger than the dimension suitable for endoluminal delivery but smaller than an unconstrained or fully deployed outer peripheral dimension, thereby facilitating selective axial and/or rotational positioning of the implant at the treatment site prior to full deployment and expansion of the implant.

Various embodiments of the present disclosure comprise a catheter assembly configured to deliver an expandable implant to a treatment area of the vasculature of a patient. In accordance with embodiments of the disclosure, the catheter assembly includes at least one apposition line. The apposition line (or lines) allows for selective bending of the expandable implant within the vasculature.

With initial reference toFIG. 1, acatheter assembly100 in accordance with the present disclosure comprises anexpandable implant106.Expandable implant106 can comprise any endoluminally-delivered expandable implant suitable for delivery to the treatment area of a vasculature. Such implants can include, for example, stents, grafts, and stent grafts.

In various embodiments,expandable implant106 comprises a stent graft. Conventional stent grafts are designed to dilate from their delivery diameter, through a range of intermediary diameters, up to a maximal, pre-determined functional diameter, and generally comprise one or more stent components with one or more graft members displaced over and/or under the stent.

In various embodiments,expandable implant106 comprises one or more stent components made of nitinol and a graft member made of ePTFE. However, and as discussed below, any suitable combination of stent component(s) and graft member(s) is within the scope of the present disclosure.

Stent components can have various configurations such as, for example, rings, cut tubes, wound wires (or ribbons) or flat patterned sheets rolled into a tubular form.

Stent components can be formed from metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol and biologically derived materials such as bovine arteries/veins, pericardium and collagen. Stent components can also comprise bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters). Any expandable stent component configuration which can be delivered by a catheter is in accordance with the present disclosure.

Moreover, potential materials for graft members include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfouorelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments for a graft member material can include high strength polymer fibers such as ultra high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). The graft member can include a bioactive agent. In one embodiment, an ePTFE graft includes a carbon component along a blood contacting surface thereof. Any graft member that can be delivered by a catheter is in accordance with the present disclosure.

In various embodiments, a stent component and/or graft member can comprise a therapeutic coating. In these embodiments, the interior or exterior of the stent component and/or graft member can be coated with, for example, a CD34 antigen. Additionally, any number of drugs or therapeutic agents can be used to coat the graft member, including, for example heparin, sirolimus, paclitaxel, everolimus, ABT-578, mycophenolic acid, tacrolimus, estradiol, oxygen free radical scavenger, biolimus A9, anti-CD34 antibodies, PDGF receptor blockers, MMP-1 receptor blockers, VEGF, G-CSF, HMG-CoA reductase inhibitors, stimulators of iNOS and eNOS, ACE inhibitors, ARBs, doxycycline, and thalidomide, among others.

In various embodiments,expandable implant106 can comprise a radially collapsed configuration suitable for delivery to the treatment area of the vasculature of a patient.Expandable implant106 can be constrained in a radially collapsed configuration and mounted onto a delivery device such ascatheter shaft102. The diameter of theexpandable implant106 in the collapsed configuration is small enough for the implant to be delivered through the vasculature to the treatment area. In various embodiments, the diameter of the collapsed configuration is small enough to minimize the crossing profile ofcatheter assembly100 and reduce or prevent tissue damage to the patient. In the collapsed configuration, theexpandable implant106 can be guided bycatheter shaft102, or another suitable delivery device, through the vasculature.

In various embodiments,expandable implant106 can comprise a radially expanded configuration suitable for delivering deployment of the implant at the treatment area of a patient's vasculature. In the expanded configuration, the diameter ofexpandable implant106 can be approximately the same as the vessel to be repaired. In other embodiments, the diameter ofexpandable implant106 in the expanded configuration can be slightly larger than the vessel to be treated to provide a traction fit within the vessel.

In various embodiments,expandable implant106 can comprise a self-expandable implant, such as a self-expandable stent graft. Such implants dilate from a radially collapsed configuration to a radially expanded configuration when unrestrained. In other embodiments,expandable implant106 can comprise an implant that is expanded with the assistance of a secondary device such as, for example, a balloon. In yet other embodiments,catheter assembly100 can comprise a plurality ofexpandable implants106. The use of a catheter assembly with any number of expandable implants is within the scope of the present disclosure.

Various expandable implants in accordance with the disclosure comprise a sleeve or multiple sleeves. The sleeve or sleeves can constrain an expandable implant in a collapsed configuration for endoluminal delivery of the implant to a treatment portion of the vasculature of a patient. For the purposes of the disclosure, the term “constrain” can mean (i) to limit the expansion, either through self-expansion or assisted by a device, of the diameter of an expandable implant or (ii) to cover or surround but not otherwise restrain an expandable implant (e.g., for storage or biocompatibility reasons and/or to provide protection to the expandable implant and/or the vasculature). For example,catheter assembly100 comprises sleeve104. Sleeve104 surrounds and constrainsexpandable implant106 to a reduced diameter.

After deployment, the sleeve or sleeves can be removed in order to allow the expandable implant to expand to its functional diameter and achieve the desired therapeutic outcome. The sleeve or sleeves can remain implanted while not interfering with the expandable implant.

In various embodiments, an expandable implant is constrained by a single sleeve which circumferentially surrounds the expandable implant. For example, with reference toFIG. 1,catheter assembly100 comprises a sleeve104. In various embodiments, sleeve104 circumferentially surroundsexpandable implant106 and constrains it in a collapsed configuration, in which the diameter is less than the diameter of the unconstrained implant. For example, sleeve104 can constrainexpandable implant106 in a collapsed configuration for delivery within the vasculature.

In other embodiments, an expandable implant is constrained by a plurality of sleeves which circumferentially surround the expandable implant. The plurality of sleeves can comprise at least two sleeves which circumferentially surround each other.

In various embodiments, sleeves can be tubular and serve to constrain an expandable implant. In such configurations, sleeves are formed from a sheet of one or more materials wrapped or folded about the expandable implant. While the illustrative embodiments herein are described as comprising one or more tubular sleeves, sleeves of any non-tubular shape that corresponds to an underlying expandable implant or that are otherwise appropriately shaped for a given application are also within the scope of the present disclosure.

In various embodiments, sleeves are formed by wrapping or folding the sheet of material(s) such that two parallel edges of the sheet are substantially aligned. Said alignment can or cannot be parallel to or coaxial with the catheter shaft of a catheter assembly. In various embodiments, the edges of the sheet of material(s) do not contact each other.

In various embodiments, the edges of the sheet of material(s) do contact each other and are coupled with a coupling member (as described below), an adhesive, or the like. In various other embodiments, the edges of the sheet of material(s) are aligned so that the edges of the same side of the sheet or sheets (e.g., the front or back of the sheet) are in contact with each other. In still other embodiments, the edges of opposite sides of the sheet of material(s) are in contact with each other, such that the edges overlap each other, such that a portion of one side of the sheet is in contact with a portion of the other side. Said another way, the front of the sheet can overlap the rear of the sheet, or vice versa.

In various embodiments, sleeves comprise materials similar to those used to form a graft member. For example, a precursor flexible sheet used to make the sleeve can be formed from a flattened, thin wall ePTFE tube. The thin wall tube can incorporate “rip-stops” in the form of longitudinal high strength fibers attached or embedded into the sheet or tube wall.

The sheet of material(s) used to form the sleeve(s) can comprise a series of openings, such that the openings extend from one edge of the sheet to the other. In such configurations, a coupling member can be woven or stitched through the series of openings in the sheet of material(s), securing each of the two edges together and forming a tube. For example, inFIG. 1,coupling member134 secures the edges of sleeve104 such that sleeve104 maintainsexpandable implant106 in a reduced diameter.

In various embodiments, the coupling member can comprise a woven fiber. In other embodiments, the coupling member can comprise a monofilament fiber. Any type of string, cord, thread, fiber, or wire which is capable of maintaining a sleeve in a tubular shape is within the scope of the present disclosure.

In various embodiments, a single coupling member can be used to constrain the diameter of one or more sleeves. In other embodiments, multiple coupling members can be used to constrain the diameter of one or more sleeves.

In various embodiments, once a suitable expandable implant is in a collapsed configuration, the expandable implant can be deployed within the vasculature of a patient. An expandable implant in a collapsed configuration can be introduced to a vasculature and directed by a catheter assembly to a treatment area of the vasculature. Once in position in the treatment area of the vasculature, the expandable implant can be expanded to an expanded configuration.

In various embodiments, when the expandable implant is in position within the vasculature, the coupling member or members can be disengaged from the sleeve or sleeves from outside of the body of the patient, which allows the sleeve(s) to open and the expandable implant to expand. As discussed above, the expandable implant can be self-expanding, or the implant can be expanded by a secondary device, such as a balloon.

The coupling member or members can be disengaged from the sleeve or sleeves by a mechanical mechanism operated from outside of the body of the patient. For example, the member or members can be disengaged by applying sufficient tension to the member or members. In another example, a dial or rotational element can be attached to the coupling member or members outside of the body. Rotation of the dial or rotational element can provide sufficient tension to, displace and disengage the coupling member or members.

In other configurations, coupling member or members can be disengaged by non-mechanical mechanisms, such as, for example, dissolution, by providing ultrasonic energy. In such configurations, sufficient ultrasonic energy is provided to coupling member or members to disengage them from the sleeve or sleeves.

In various embodiments, disengaging a single coupling member which closes a single sleeve from the sleeve allows the expandable implant to be expanded. For example, with reference toFIG. 1,catheter assembly100 can be used to deliver an implantexpandable implant106 to a treatment area of a vasculature.Expandable implant106 has a collapsed diameter for delivery, and sleeve104 circumferentially surroundsexpandable implant106 and is held closed by couplingmember134. As described in more detail below, bending ofexpandable implant106 can be controlled prior to full expansion (e.g., at an intermediate diameter) to help facilitate delivery to the desired position. Onceexpandable implant106 is in position relative to the treatment area,coupling member134 is disengaged from sleeve104 and sleeve104 is released, allowingexpandable implant106 to expand to a larger diameter.

As mentioned above, in various embodiments of the present disclosure, an expandable implant can further comprise an intermediate configuration. In the intermediate configuration, the diameter of the expandable implant is constrained in a diameter smaller than the expanded configuration and larger than the collapsed configuration. For example, the diameter of the expandable implant in the intermediate configuration can be about 50% of the diameter of the expandable implant in the expanded configuration. However, any diameter of the intermediate configuration which is less than the diameter of the expanded configuration and larger than the collapsed configuration is within the scope of the invention.

In such embodiments, the expandable implant can be expanded from the collapsed configuration to the intermediate configuration once the implant has been delivered near the treatment area of the vasculature of a patient. The intermediate configuration can, among other things, assist in properly orienting and locating the expandable implant within the treatment area of the vasculature.

In various embodiments, an expandable implant can be concentrically surrounded by two sleeves having different diameters. In such configurations, a primary sleeve constrains the expandable implant in the collapsed configuration. Once the collapsed configuration sleeve is opened, a secondary sleeve constrains the expandable implant in the intermediate configuration. As discussed above, the expandable implant can be self-expanding, or the implant can be expanded by a secondary device, such as a balloon.

For example, with reference toFIG. 2, acatheter assembly100 comprises anexpandable implant106 andsecondary sleeve204.Secondary sleeve204 constrainsexpandable implant106 to an intermediate configuration.Secondary sleeve204 is held in position aroundexpandable implant106 bysecondary coupling member224.

Catheter assembly100 further comprisesprimary sleeve208, which constrainsexpandable implant106 in a collapsed configuration for delivery to the vasculature of a patient.Primary sleeve208 is held in position aroundexpandable implant106 byprimary coupling member234.

Onceexpandable implant106 is sufficiently close to the treatment area of the vasculature,primary coupling member234 is disengaged fromprimary sleeve208, which releasesprimary sleeve208 and allows expandedimplant106 to expand to a larger diameter.

Afterprimary sleeve208 has been expanded,secondary sleeve204 constrains theexpandable implant106 in the intermediate configuration. In the intermediate configuration, as mentioned above and as described in more detail below,expandable implant106 can be oriented and adjusted (e.g., by bending and torsional rotation) to a desired location within the treatment area of the vasculature.

In other embodiments of the present disclosure, a single sleeve can be used to constrain the expandable implant in both a collapsed configuration and an intermediate configuration. For example, with reference toFIGS. 3A-3E,catheter assembly100 comprises anexpandable implant106, amonosleeve304, aprimary coupling member334, and asecondary coupling member324.

Monosleeve304 further comprises a plurality ofsecondary holes332. In this configuration,secondary coupling member324 is stitched or woven throughsecondary holes332, constrictingmonosleeve304 andexpandable implant106 to the diameter of an intermediate configuration. In the intermediate configuration, the diameter ofexpandable implant106 is less than the expanded diameter and larger than the diameter of the collapsed configuration. In the intermediate configuration, as described in more detail below,expandable implant106 can be oriented and adjusted (e.g., by bending and torsional rotation) to a desired location within the treatment area of the vasculature.

Monosleeve304 further comprises a plurality ofprimary holes330. In this configuration,primary coupling member334 is stitched or woven throughprimary holes330, constrictingmonosleeve304 andexpandable implant106 to the diameter of the collapsed configuration. The diameter of the collapsed configuration is selected to allow for delivery of theexpandable implant106 to the treatment area of the vasculature of a patient.

Onceexpandable implant106 has been delivered to a region near the treatment area of the vasculature,primary coupling member334 can be disengaged frommonosleeve304, allowingexpandable implant106 to be expanded to the intermediate configuration.Expandable implant106 can be oriented and adjusted (e.g., by bending and torsionally rotating) to a desired location within the treatment area of the vasculature. After final positioning,secondary coupling member324 can be disengaged frommonosleeve304, andexpandable implant106 can be expanded to the expanded configuration.

Although a number of specific configurations of constraining members (for example, primary and secondary members) and sleeves (for example, primary and secondary sleeves) have been discussed, the use of any number and/or configuration of constraining members and any number of sleeves is within the scope of the present disclosure.

In various embodiments,catheter assembly100 further comprises a lockwire. Such a lockwire can be used to interact with and secure one or more portions of an expandable implant to a catheter shaft to orient and assist in positioning the expandable implant. For example, with initial reference toFIGS. 4A, 4B, and 5,catheter assembly100 comprising acatheter shaft102 and alockwire410 is illustrated.Catheter shaft102 can comprise one ormore ports436. In various embodiments, lockwire410 extends from the trailing end ofcatheter assembly100 throughcatheter shaft102, exits aport436, interacts withexpandable implant106, and reenterscatheter shaft102 through aport436, wherein the exit and reentry port(s) can be the same or different port(s). As illustrated inFIG. 4B, lockwire410 can be disengaged withexpandable implant106 by applying sufficient tension in the direction of the trailing end ofcatheter assembly100, causinglockwire410 to be withdrawn and/or to break. However, any manner of securing an expandable implant to the catheter shaft to facilitate orientation and positioning of the expandable implant is within the scope of the present disclosure.

In various embodiments,expandable implant106 can comprise an apposition line which allows a user or operator to control the curvature ofexpandable implant106. For example, an apposition line can be configured to facilitate deployment ofexpandable implant106 at tortuous treatment sites, such as the aortic arch, where an end ofexpandable implant106 might otherwise fail to conform, engage, and form a seal with the surrounding tissue due to straightening out or rotation of the expandable implant.

For example, with initial reference toFIG. 6B, acatheter assembly100 comprising anapposition line620 is illustrated. In various embodiments,apposition line620 can interact withcatheter shaft102 andexpandable implant106 to allow for manipulation of the shape ofexpandable implant106 by the user or operator ofcatheter assembly100. For example, tension can be applied toapposition line620 to bendexpandable implant106 to a desired shape and/or curvature.Apposition line620 can, for example, maintain a curvature which generally conforms to the shape of, for example, a tortuous anatomy. Maintaining such a curvature can allowexpandable implant106 to fully engage the surrounding tissue and form a seal.

In various embodiments,apposition line620 can extend from the trailing end ofcatheter assembly100 throughcatheter shaft102 to the distal end ofexpandable implant106. For example,apposition line620 can extend from the trailing end ofcatheter assembly100 throughcatheter shaft102 to aside port626, where it exitscatheter shaft102 throughside port626 and extends to the distal end ofexpandable implant106. In such configurations,apposition line620 can engage with the distal end ofexpandable implant106. While apposition line can terminate at the distal end ofexpandable implant106, in various embodiments,apposition line620 can extend from the distal end ofexpandable implant106 back towardsside port626, enter the port, and return toward the trailing end ofcatheter assembly100.

With initial reference toFIG. 7, in embodiments in whichexpandable implant106 is a stent, asingle apposition line620 can engage with the distal end ofexpandable implant106 by, for example, looping around one or morewire frame apices652. In embodiments in whichexpandable implant106 is a stent graft,apposition line620 can loop aroundwire frame apices652 and/or through the side wall of the graft member ofexpandable implant106. However, any manner in whichapposition line620 can be engage with an expandable implant such that the curvature of the implant can be controlled is within the scope of the present disclosure.

In various embodiments,apposition line620 can comprise can comprise metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol. Elongated members or lock wires can also be formed from high strength polymer fibers such as ultra high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). However, any material capable of providing sufficient tension to and maintaining the curvature of an expandable implant is within the scope of the present disclosure.

With reference toFIGS. 6A-6D, cross-sectional views of various expandable implant configurations are illustrated.FIGS. 6A-6D generally illustrate a deployment sequence ofcatheter assembly100 utilizingapposition line620 to maintain a curvature ofexpandable implant106 as the implant deployed along a curved or tortuous anatomy, such as, for example, the aortic arch.

As illustrated inFIG. 6A,expandable implant106 comprises a stent graft.Expandable implant106 is constrained in the collapsed configuration by, for example, a flexible constraining sleeve, and deployed endoluminally toward a treatment site in the body of a patient.

FIG. 6B illustratesexpandable implant106 in an intermediate configuration. In such embodiments,catheter shaft102 can comprise aside port626.Side port626 can be located at a position oncatheter shaft102 between the proximal and distal ends ofexpandable implant106.

In various embodiments,expandable implant106 can be secured tocatheter shaft102 near the proximal and/or distal ends ofexpandable implant106. For example, as illustrated inFIGS. 6B-6D,expandable implant106 is secured tocatheter shaft102 bylockwire410 at both the proximal and distal ends ofexpandable implant106. In the illustrated embodiment, the portion ofexpandable implant106 secured at the distal end is approximately 180 degrees out of phase with the portion ofexpandable implant106 secured at the proximal end. This configuration offsetscatheter shaft102 in relation toexpandable implant106. Stated another way, in such configurations,catheter shaft102 is not parallel to a longitudinal axis ofexpandable implant106. However, any relative orientation ofcatheter shaft102 andexpandable implant106 which permits the proper orientation and positioning ofexpandable implant106 is within the scope of the present disclosure.

As illustrated inFIGS. 6B-6D,catheter assembly100 can comprise anapposition line620. In such embodiments,apposition line620 extends from the trailing end ofcatheter assembly100 throughcatheter shaft102 and exitsside port626.Apposition line620 further extends to the distal end of and engagesexpandable implant106, then returns tocatheter shaft102 throughside port626.

In various embodiments, with initial reference toFIG. 6C, further deployment ofexpandable implant106 can be initiated by partially releasingsecondary coupling member224. For example, assecondary coupling member224 is partially released, the distal end ofexpandable implant106 can begin to expand to the expanded configuration. In such embodiments, as the distal end expands, tension applied toapposition line620 causes the distal end to curve in a desired direction. For example, as illustrated inFIG. 6C, the distal end ofexpandable implant106 can curve away fromcatheter tip140.

As illustrated inFIGS. 6C and 6D, assecondary coupling member224 is released fromexpandable implant106, tension applied toapposition line620 can causeexpandable implant106 to conform to a desiredcurvature1050. In various embodiments, the shape ofcurvature1050 is dependent on a number of factors, such as, for example, the position ofside port626 alongcatheter shaft102 and the resilience ofexpandable implant106, among others.Curvature1050 can be chosen to correspond with the shape and/or profile of a portion of the treatment area, such as, for example, a vessel. Once asuitable curvature1050 is selected, the attributes ofcatheter assembly100 can be selected to providecurvature1050.

In various embodiments,catheter assembly100 further comprises an end-constraining element. For example, an end-constraining element can assist in controlling the outer peripheral dimension of an end ofexpandable implant106 to facilitate repositioning of the implant during deployment at the treatment site. For example, with initial reference toFIG. 8,catheter assembly100 comprises an end-constraining constrainingelement612. In such configurations, end-constrainingelement612 can assist in maintainingexpandable implant106 in a compressed and/or intermediate configuration.

As illustrated inFIG. 8, end-constrainingelement612 can be configured to concentrically surround the distal end ofexpandable implant106. In various embodiments, end-constrainingelement612 comprises a thread or fiber that extends from the trailing end ofcatheter assembly100, throughcatheter shaft102, and to the distal end ofexpandable implant106. During deployment ofexpandable implant106, tension can be applied to end-constrainingelement612 to maintain the distal end in a collapsed and/or intermediate configuration. By selectively releasing the tension applied to end-constrainingelement612, the rate of expansion of the distal end ofexpandable implant106 which can, for example, assist in conformingexpandable implant106 to a desired curvature.

For example, end-constrainingelement612 can be controlled such that movement of a dial or other control mechanism in a first direction relative tocatheter shaft102 shortens the portion of the element that extends aroundexpandable implant106, radially compressing the implant. Movement of a dial or control mechanism in an opposite second direction relative tocatheter shaft102 lengthens the portion of element that extends aroundexpandable implant106, allowing radial expansion of the implant. Thus, selective displacement of the movable element between the first and second directions results in compression and expansion, respectively, ofexpandable implant106 to facilitate positioning of the implant during deployment at the treatment site.

In various embodiments,catheter assembly100 further comprises two ormore apposition lines620. Multiple apposition lines can assist, for example, in conformingexpandable implant106 to a desired curvature. For example, with initial reference toFIG. 9,catheter assembly100 can comprise twoapposition lines620. In such configurations, eachapposition line620 can engage withapices652 ofexpandable implant106.

With returned reference toFIG. 8,catheter assembly100 can further comprise one ormore eyelets814. In various embodiments,eyelets814 can be located at the end of eachapposition line620 nearest the distal end ofexpandable implant106. As illustrated inFIG. 8,catheter assembly100 can comprisemultiple apposition lines620, each comprising aneyelet814. In such embodiments, end-constrainingelement612 can be configured such that the element passes through both the distal end ofexpandable implant106 and one ormore eyelets814 ofapposition lines620.

In various embodiments, as illustrated inFIG. 10,catheter assembly100 comprises ashrink tube1048. For example,apposition line620 can extend throughshrink tube1048 towards the distal end ofexpandable implant106, engage with a portion of the implant, and return throughshrink tube1048 to the proximal end of the implant. In such configurations,apposition line620 can comprise aneyelet1044. Eyelet can, for example, engage with end-constraining element. Such engagement can help maintain the relative positions of apposition line and end-constraining element.

In various embodiments,catheter assembly100 can comprise one ormore apposition lines620. For example,apposition lines620 can extend throughshrink tube1048 to the distal end ofexpandable element106. In such configurations,apposition lines620 can be simultaneously actuated relative tocatheter shaft102. Alternatively, eachapposition line620 can be configured for separate actuation to provide additional control curvature ofexpandable implant106.

After a sufficient degree of bending has been achieved inexpandable implant106, such as, for example, by achieving a desired curvature, theexpandable implant106 can be rotated for final positioning in the treatment area of the vasculature. In various exemplary embodiments, lockwire410 is engaged withapposition line620 such that torsional rotation of the catheter shaft causesexpandable implant106 to rotate within the vasculature. However, any configuration ofcatheter assembly100 which allows for rotation ofexpandable implant106 is within the scope of the present disclosure.

In various embodiments, an expandable implant can further comprise one or more radiopaque markers. In one embodiment, one or more radiopaque markers form a band around the distal end of the expandable implant. In such configurations, the radiopaque markers can assist in deployment of an expandable implant by providing increased visibility when observing the expandable implant with a radiographic device, such as an x-ray machine. Any arrangement of radiopaque markers which assists in deployment of an expandable implant is within the scope of the present disclosure.

For example, radiopaque markers can assist in orienting the expandable implant by providing a profile view of the distal end of the expandable implant. For example, with reference toFIG. 11, a number of potential profiles1191-1194 of the distal end of anexpandable implant106 are illustrated. In such configurations, radiopaque markers located in the distal end ofexpandable implant106 provide a profile view of the distal end ofexpandable implant106 when viewed by a radiographic device. Such profile views can be used to properly orientexpandable implant106 by assisting a user in determining the degree of rotation and/or orientation of a bend inexpandable implant106.

For example,profile1191 represents a distal end of anexpandable implant106 having an orientation substantially orthogonal to a radiographic image capture device, such as an x-ray camera.Profile1192 represents a distal end of an expandable implant having an orientation less orthogonal thanprofile1191.Profile1193 represents a distal end of anexpandable implant106 having an orientation less orthogonal thanprofile1192. Finally,profile1194 represents a distal end of anexpandable implant106 having an orientation parallel to a radiographic image capture device.

Afterexpandable implant106 has been properly oriented and located within the treatment area of the patient,secondary coupling member224 can be disengaged fromsecondary sleeve204. Oncesecondary coupling member224 is disengaged fromsecondary sleeve204,expandable implant106 can be expanded to a final position and diameter within the treatment area. In various exemplary embodiments,secondary sleeve204 is removed from the vasculature. In other exemplary embodiments,secondary sleeve204 remains in position circumferentially surrounding a portion ofexpandable implant106.

Upon full deployment ofexpandable implant106,catheter shaft102 can be disengaged fromexpandable implant106 to allowcatheter assembly100 to be removed from the body of the patient. In various embodiments,catheter shaft102 is disengaged fromexpandable implant106 by removinglockwire410. In various embodiments, as illustrated inFIGS. 6A-6D,catheter shaft102 is engaged bylockwire410 to portions of the distal and proximal ends ofexpandable implant106. In such embodiments, tension is applied tolockwire410, causing it to break and/or disengaged from both ends ofexpandable implant106, disengagingcatheter shaft102 from the implant.

In various embodiments,apposition line620 can be disengaged from the distal end ofexpandable implant106. For example, sufficient tension can be applied toapposition line620 to breakapposition line620. In other configurations, for example shown inFIG. 10,apposition wire620 is released when lockwire410 is disengaged and/or broken.

In other embodiments, one ormore apposition lines620 are engaged with end-constrainingelement612. In such configurations, for example as shown inFIG. 8, end-constrainingelement612 can be disengaged fromeyelets814 ofapposition lines620, allowing for removal of both end-constrainingelement612 and the one ormore apposition lines620.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents.

Likewise, numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.

Claims (20)

What is claimed is:

1. A catheter assembly comprising:

a catheter having a leading end and a trailing end and comprising a main lumen extending between the leading end and the trailing end and a side port;

an expandable implant having a proximal end and a distal end and positioned between the leading end and trailing end of the catheter, the expandable implant having a collapsed configuration for endoluminal delivery of the expandable implant to a treatment site and an expanded configuration having a diameter larger than the diameter of the collapsed configuration,

wherein the side port is located along the main lumen of the catheter at a position between the proximal end and the distal end of the expandable implant;

a primary sleeve wrapped circumferentially around the expandable implant, wherein the primary sleeve comprises a sheet of material having first and second major surfaces and a plurality of openings extending from the first major surface to the second major surface; and

a primary coupling member cooperating with the plurality of openings of the sheet for releasably coupling portions of the sheet to one another to constrain the expandable implant in the collapsed configuration;

a lockwire arranged through the expandable implant adjacent at least one of the proximal end and the distal end thereof, the lockwire being configured to releasably couple the expandable implant to the catheter; and

at least one apposition line including an eyelet through which the lock wire is arranged and being configured to maintain a longitudinal curvature of the expandable implant during expansion of the expandable implant and release when the lockwire is disengaged from the catheter, the at least one apposition line being arranged to extend through the main lumen of the catheter and through the side port of the catheter to engage at least a portion of the expandable implant through a wall of the expandable implant near the distal end and return to the main lumen of the catheter through the side port during engagement of the at least one apposition line with the expandable implant.

2. The catheter assembly ofclaim 1, further comprising a secondary sleeve and secondary coupling member, wherein the secondary sleeve limits expansion of the expandable implant to an intermediate configuration having a diameter larger than the diameter of the collapsed configuration and smaller than the diameter of the expanded configuration, and wherein the apposition line is configured to release from the portion of the expandable implant upon disengaging of the lockwire.

3. The catheter assembly ofclaim 1, wherein the expandable implant comprises a stent graft.

4. The catheter assembly ofclaim 1, further comprising a secondary coupling member and a plurality of secondary openings, wherein the secondary coupling member cooperates with the plurality of secondary openings for releasably coupling portions of the sheet to one another to constrain the expandable implant in an intermediate configuration, the intermediate configuration having a diameter larger than the collapsed configuration and smaller than the expanded configuration.

5. The catheter assembly ofclaim 1, further comprising a plurality of apposition lines.

6. The catheter assembly ofclaim 1, wherein the expandable implant is bendable more than about 90 degrees relative to an axis of the catheter.

7. The catheter assembly ofclaim 1, wherein the expandable implant is releasably coupled to the catheter.

8. The catheter assembly ofclaim 7, wherein the catheter further comprises a pair of distal end ports and the lockwire exits the main lumen through one of the pair of distal end ports, engages the expandable implant, and enters the main lumen through the other of the pair of distal end ports to removably couple the catheter and the distal end of the expandable implant.

9. The catheter assembly ofclaim 1, wherein the expandable implant substantially maintains a desired curvature while the expandable implant is deployed to the expanded configuration.

10. The catheter assembly ofclaim 1, further comprising a radiopaque marker located at the proximal end of the expandable implant.

11. The catheter assembly ofclaim 10, wherein the radiopaque marker comprises a band extending around a perimeter of the expandable implant.

12. A method for deploying an expandable implant comprising:

providing a catheter assembly ofclaim 1;

introducing the leading end of the catheter assembly into a body of a patient;

navigating the leading end of the catheter assembly to the proximity of a treatment area;

partially expanding the expandable implant;

applying tension to the at least one apposition line to achieve a desired curvature in the expandable implant;

fully expanding the expandable implant; and

disengaging the at least one apposition line from the expandable implant.

13. The method ofclaim 12, wherein the catheter assembly further comprises a secondary coupling member and a plurality of secondary openings, wherein the secondary coupling member cooperates with the plurality of secondary openings for releasably coupling portions of the sheet to one another to constrain the expandable implant in an intermediate configuration, the intermediate configuration having a diameter larger than the collapsed configuration and smaller than the expanded configuration.

14. The method ofclaim 13, wherein the step of fully expanding the expandable implant comprises disengaging the primary coupling member to expand the expandable implant to the expanded configuration.

15. The method ofclaim 12, wherein the catheter assembly further comprises a secondary sleeve and secondary coupling member, wherein the secondary sleeve limits expansion of the expandable implant to an intermediate configuration having a diameter larger than the diameter of the collapsed configuration and smaller than the diameter of the expanded configuration.

16. The method ofclaim 12, wherein the catheter assembly further comprises a plurality of apposition lines.

17. The method ofclaim 12, wherein the catheter further comprises a pair of distal end ports and the lockwire exits the main lumen through one of the pair of distal end ports, engages the expandable implant, and enters the main lumen through the other of the pair of distal end ports to removably couple the catheter and the distal end of the expandable implant.

18. The method ofclaim 12, wherein the expandable implant is a self-expanding stent graft.

19. The method ofclaim 12, wherein the catheter assembly further comprises an end-constraining element located at the proximal end of the expandable implant and configured to maintain the proximal end of the expandable implant in the collapsed configuration.

20. The method ofclaim 19, wherein the catheter assembly further comprises a lockwire configured to couple a portion of the end-constraining element and the catheter.

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